UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038528 |
|---|---|
| Receipt number | R000043719 |
| Scientific Title | Examination of educational effects and influencing factors of complex exercise programs for elderly people participating in community-based attendance.cluster randomized controlled trial |
| Date of disclosure of the study information | 2019/11/09 |
| Last modified on | 2020/06/16 15:51:02 |
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Basic information
Public title
Examination of educational effects and influencing factors of complex exercise programs for elderly people participating in community-based attendance.cluster randomized controlled trial
Acronym
Examination of educational effects and influencing factors of complex exercise programs for elderly people participating in community-based attendance.cluster randomized controlled trial
Scientific Title
Examination of educational effects and influencing factors of complex exercise programs for elderly people participating in community-based attendance.cluster randomized controlled trial
Scientific Title:Acronym
Examination of educational effects and influencing factors of complex exercise programs for elderly people participating in community-based attendance.cluster randomized controlled trial
Region
| Japan |
Condition
Condition
Elderly people
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the educational effects of exercise programs and brain activation programs for elderly people participating in community-based places of attendance.
Basic objectives2
Others
Basic objectives -Others
Consider factors that affect effectiveness.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function
Key secondary outcomes
1)Motor function.
Grip strength, long-bend bend, 30 second chair standing up test, standing on one leg.
2)Comprehensive activity
Life-Space Assessment, Falls Efficacy Scale, Bathing action, Continuous walking distance, Lubben Social Network Scale(LSNS-6)
3)Social capital indicators.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
One video gymnastics instruction for stretching and strength training.
Video exercise for stretching and strength training 30 minutes,24 weeks of activity frequency at the place of attendance.
Interventions/Control_2
One instruction for video exercises for stretching and strength training, and two instructions for brain activation program.
Video exercise for stretching and strength training 30 minutes + brain activation program 10 minutes through the activity frequency of the place for 24 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
cluster
1)It is a communal place that municipalities judge to do gymnastics and hobbies, and to help prevent nursing care
2)Residents are responsible for managing the attendance
3)The management of commuting places is not limited to those where municipalities provide financial support
4)Have an activity record of at least once a month
Individual unit
1)Those who are at risk or who are concerned about their health condition have obtained a doctor's consent form
Key exclusion criteria
cluster
1)A place for attendance of up to 7 participants
Individual unit
1)Doctors determined that study participation is inappropriate
2)Those with cardiovascular, respiratory, neurological or orthopedic disorders that limit the performance of exercise and assessment
3)Persons with dysarthria or aphasia who cannot communicate
4)Those under 65 years old
Target sample size
58
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Sakata |
Organization
Chizu hospital
Division name
Department of rehabilitation
Zip code
6891402
Address
1875 Chizu town,Tottori,Japan
TEL
0858-75-3211
chiz@town.chizu.tottori.jp
Public contact
Name of contact person
| 1st name | Yusuke |
| Middle name | |
| Last name | Sakata |
Organization
Chizu hospital
Division name
Department of rehabilitation
Zip code
6891402
Address
1875 Chizu town,Tottori,Japan
TEL
0858-75-3211
Homepage URL
chiz@town.chizu.tottori.jp
Sponsor or person
Institute
Chizu hospital
Department of rehabilitation
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research ethics committee of Japan Physical Therapy Association
Address
3-8-5 Sendagaya,Sibuya,Tokyo,Japan
Tel
03-6804-1626
ethics@japanpt.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
0
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2019 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 09 | Day |
Last modified on
| 2020 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043719
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
